Calcium Administration in Cardiac Surgery

  • STATUS
    Recruiting
  • End date
    Mar 30, 2022
  • participants needed
    818
  • sponsor
    Meshalkin Research Institute of Pathology of Circulation
Updated on 28 January 2021
heparin
haemostasis
reperfusion injury
heart surgery
cardiopulmonary bypass
0.9% sodium chloride
hemodilution
acute pancreatitis
bypass surgery
inotropic agents

Summary

Termination of cardiopulmonary bypass is a critical step in any cardiac surgical procedure and requires a thorough planning. Debate about rationale of calcium administration during weaning of cardiopulmonary bypass has been conducted for several decades; however, a consensus has not been yet reached.

Perioperative hypocalcemia can develop because of haemodilution or calcium binding from heparin, albumin and citrate. Perioperative hypocalcemia is often complicated by development of arrhythmias, especially QT interval prolongation. Furthermore, low content of calcium can lead to vascular tone disorders, violation of neuromuscular transmission, altered hemostasis and heart failure, resistant to inotropic agents, especially in patients with concomitant cardiomyopathy.

On the other hand, hypercalcaemia is a dangerous complication in cardiac surgery. Among the fatal, but rather rare complications, there are acute pancreatitis and the phenomenon of the "stone heart", which is essentially a reperfusion injury of the myocardium caused by rapid calcium overload. Hypercalcaemia can also trigger rhythm disturbances, hypertension, increase systemic vascular resistance, reduce diastolic compliance and impair relaxation of the myocardium due to excessive calcium intake into the cardiomyocytes, cause coronary vasospasm and aggravate ischaemic myocardial damage, impair arterial graft blood flow during aortocoronary and mammary coronary bypass surgery.

To date, there is a lack of data indicating clinical efficacy of calcium administration before separation from CPB. Therefore, we designed this randomized controlled trial to test the hypothesis whether calcium administration at termination of CPB will reduce the need for inotropic support at the end of surgery.

Details
Condition Thoracic Surgery, heart surgery, Cardiopulmonary Bypass, Cardiac Surgery, heart/lung bypass, cardiac operation
Treatment 0.9% sodium chloride, Calcium chloride
Clinical Study IdentifierNCT03772990
SponsorMeshalkin Research Institute of Pathology of Circulation
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Thoracic Surgery or Cardiac Surgery or Cardiopulmonary Bypass or heart surgery?
Do you have any of these conditions: heart surgery or heart/lung bypass or Thoracic Surgery or cardiac operation or Cardiopulmonary Bypass or Cardiac Surgery?
Do you have any of these conditions: Thoracic Surgery or Cardiac Surgery or Cardiopulmonary Bypass or heart/lung bypass or cardiac operation or heart surgery?
surgery under cardiopulmonary bypass
valve or valve surgery + CABG
age > 18 years
signed informed consent

Exclusion Criteria

emergency surgery
isolated aortic valve repair/replacement
planned (before surgery) blood transfusion
redo surgery
known allergy to the study drug
pregnancy
current enrollment into another RCT (in the last 30 days)
previous enrollment and randomization to ICARUS trial
liver cirrhosis (Child B or C)
transfusion during CPB
hypo- or hyperparathyreosis
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